# \[e-drug\] Colombian Groups Seek Generic AIDS Drug; Secret Treaty May Interfere with Generic Meds

**URL:** <https://talk.edrugplus.org/t/e-drug-colombian-groups-seek-generic-aids-drug-secret-treaty-may-interfere-with-generic-meds/30333>\
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**Created:** [August 7, 2008, 4:56pm UTC](https://talk.edrugplus.org/t/e-drug-colombian-groups-seek-generic-aids-drug-secret-treaty-may-interfere-with-generic-meds/30333 "2008-08-07T16:56:03Z")\
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**Author:** ![Sarah\_Rimmington](https://avatars.discourse-cdn.com/v4/letter/s/b5e925/32.png) [@Sarah\_Rimmington](https://talk.edrugplus.org/u/Sarah_Rimmington)\
**Post date:** [August 7, 2008, 4:56pm UTC](https://talk.edrugplus.org/t/e-drug-colombian-groups-seek-generic-aids-drug-secret-treaty-may-interfere-with-generic-meds/30333/1 "2008-08-07T16:56:03Z")

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E-DRUG: Colombian Groups Seek Generic AIDS Drug; Secret Treaty May Interfere with Generic Meds  
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Colombian Health Organizations Seek Generic AIDS Drug

On July 16, Colombian public health and HIV/AIDS organizations stepped  
up their efforts to facilitate access to an important HIV/AIDS treatment  
by filing requests with the Colombian Government for an open compulsory  
license on lopinavir/ritonavir (brand-name Kaletra). [1] If issued, the  
compulsory license would permit the introduction of significantly more  
affordable generic versions of the drug throughout the country in  
exchange for royalty payments to the patent holder, Chicago-based Abbott  
Laboratories.

The compulsory license request comes more than three months after the  
civil society groups first requested a voluntary license directly from  
Abbott. [2] To date, the company has not responded to the groups' request.

HIV/AIDS is a serious health problem in Colombia. Official statistics  
show that from 1983 through 2007, approximately 57,500 people were  
diagnosed with the disease, though the true number of cases is estimated  
to be closer to 171,500. The groups that initiated the compulsory  
license request estimate that about 23,000 of the people living with  
HIV/AIDS in Colombia currently require antiretroviral (ARV) treatment,  
but only about 12,000 receive it. HIV/AIDS is the third leading cause of  
death for men between the ages of 15 and 44 in Colombia.

"My government must not let its people die when there exists a simple,  
affordable solution to helping people with HIV/AIDS live normal lives,"  
says Francisco Rossi of IFARMA-HAI (Health Action International), one of  
the Colombian organizations that initiated the compulsory license requests.

Lopinavir/ritonavir (LPV/r) is an important "second-generation"  
treatment for HIV/AIDS. In Colombia, only the brand-name version of the  
product (Kaletra) is available to patients. Kaletra is so expensive that  
it is unaffordable for much of the population. In a country with an  
average income of US$3250, Abbott sells Kaletra to public sector  
suppliers for approximately $1683 per patient, per year, and to private  
sector suppliers for as much as $4449. However, generic LPV/r is  
currently available in both Peru and Bolivia for less than $800 per  
patient, per year. It will also soon be available throughout Latin  
America for as little as $550 as a result of a recent Clinton Foundation  
deal. Abbott charges patients in Colombia more for Kaletra than it  
charges other countries in the region, where the company sells it for as  
little as $1000 per patient, per year.

Colombian civil society estimates that with competition the government  
alone could save well over $1 million annually. Civil society  
organizations suggested that these savings could be invested in many  
possible ways, such as scaling up the numbers of patients receiving  
HIV/AIDS treatment and strengthening Colombia's health system. [3]  
Patients and private insurers buy significantly larger quantities of  
drugs than the government, and thus the cost savings resulting from the  
introduction of generic competition for LPV/r would also be much larger  
for them.

The Colombian government can legally issue compulsory licenses on  
pharmaceutical patents under World Trade Organization and Andean  
Community rules. Under domestic law, the Colombian government is obliged  
to reply to the compulsory license request within a reasonable amount of  
time. Colombian civil society organizations will be meeting with  
government officials to discuss the request in coming weeks.

Meanwhile, at the International AIDS Conference in Mexico City  
yesterday, health advocates from around the world demonstrated and  
released a letter in support of the Colombian civil society request. [4]  
"Issuing a compulsory license in this case will help promote access to  
medicines for all," wrote the groups. The high price charged by Abbott,  
the patent holder for this medicine, constitutes a barrier to access and  
hinders efforts to make antiretroviral treatment available in Colombia  
to all who need it." [5]

Web links  
[1][http://www.essentialaction.org/access/index.php?/archives/166-Colombia-Health-Organizations-file-for-compulsory-license-on-lopinavirritonavir.html](http://www.essentialaction.org/access/index.php?/archives/166-Colombia-Health-Organizations-file-for-compulsory-license-on-lopinavirritonavir.html)  
[2] [http://lists.essential.org/pipermail/ip-health/2008-April/012527.html](http://lists.essential.org/pipermail/ip-health/2008-April/012527.html)  
[3][http://www.essentialaction.org/access/index.php?/archives/170-Health-Groups-Worldwide-Support-Colombian-Call-for-Compulsory-License-on-Kaletra.html](http://www.essentialaction.org/access/index.php?/archives/170-Health-Groups-Worldwide-Support-Colombian-Call-for-Compulsory-License-on-Kaletra.html)  
[4][http://www.essentialaction.org/access/index.php?/archives/171-Palm-Beach-Post-A-Tug-of-War,-A-Funeral,-and-Drug-Prices.html](http://www.essentialaction.org/access/index.php?/archives/171-Palm-Beach-Post-A-Tug-of-War,-A-Funeral,-and-Drug-Prices.html)  
[5][http://www.essentialaction.org/access/index.php?/archives/170-Health-Groups-Worldwide-Support-Colombian-Call-for-Compulsory-License-on-Kaletra.html](http://www.essentialaction.org/access/index.php?/archives/170-Health-Groups-Worldwide-Support-Colombian-Call-for-Compulsory-License-on-Kaletra.html)

Secret Treaty May Interfere with Generic Medicines

A new international treaty now under negotiation, known as the  
Anti-Counterfeiting Trade Agreement (ACTA), may interfere with efforts  
to promote generic and price competition for the pharmaceutical  
industry, according to public health campaigners.

The United States, the European Union, Japan, South Korea, Canada,  
Mexico, Australia and New Zealand are now negotiating ACTA. [1]

The text remains secret, but the treaty aims to establish a heightened  
common international standard for border controls and copyright,  
trademark and patent enforcement.

Over the last couple years, the brand-name pharmaceutical industry and  
its allies have increasingly called attention to the issue of  
counterfeit medicines. Industry, the U.S. government and the World  
Health Organization have implemented a daunting array of projects to  
address pharmaceutical counterfeits. ACTA would extend far beyond these  
initiatives, however.

Public health advocates say that counterfeits are a legitimate public  
health concern, but a subset of a bigger problem: substandard medicines,  
in both rich and poor countries. A public health agenda would focus on  
the quality of medicines, not narrow patent and trademark issues, they  
say. [2]

Pharma, however, is interested in the narrow focus on patent and  
trademark issues. Arguments from Pharma and its allies about  
counterfeiting blur the lines between fakes and generics -- undermining  
public confidence in generics. [3]

Pharma also uses counterfeits as a justification to oppose reimportation  
of pharmaceuticals (commonly known as parallel trade or parallel  
importation outside of the United States). Because reimported drugs move  
outside of brand-name firms' control, and may be repackaged, the  
argument runs, there is no certainty that a reimported pharmaceutical is  
legitimate.

Because the ACTA text remains secret, exactly what it contains is  
unknown. But PhRMA, the U.S. brand-name drug industry association, has  
suggested that the treaty should impose liability on manufacturers of  
active pharmaceutical ingredients (APIs), if those APIs are used to make  
counterfeits -- a liability system that may make API manufacturers  
reluctant to sell to legal generic drug makers, and thereby  
significantly damage the functioning of the legal generic pharmaceutical  
industry. Other industry recommendations would interfere with drug  
reimportation.

The G8's recent Declaration on the World Economy implored negotiators to  
include ACTA negotiations this year. [4]

For more on ACTA, see:  
[http://www.keionline.org/index.php?option=com\_content&task=view&id=187](http://www.keionline.org/index.php?option=com_content&task=view&id=187)  
[http://www.publicknowledge.org/issues/acta](http://www.publicknowledge.org/issues/acta)  
[https://secure.eff.org/site/Advocacy?JServSessionIdr009=m5722xgyi2.app2a&cmd=display&page=UserAction&id=383](https://secure.eff.org/site/Advocacy?JServSessionIdr009=m5722xgyi2.app2a&cmd=display&page=UserAction&id=383)  
[http://ipjustice.org/wp/campaigns/acta/](http://ipjustice.org/wp/campaigns/acta/)

Web links:  
[1][http://www.ustr.gov/Document\_Library/Press\_Releases/2007/October/Ambassador\_Schwab\_Announces\_US\_Will\_Seek\_New\_Trade\_Agreement\_to\_Fight\_Fakes.html](http://www.ustr.gov/Document_Library/Press_Releases/2007/October/Ambassador_Schwab_Announces_US_Will_Seek_New_Trade_Agreement_to_Fight_Fakes.html)  
[2][http://www.essentialaction.org/access/index.php?/archives/131-Comments-on-Proposed-Anti-Counterfeiting-Treaty.html#extended](http://www.essentialaction.org/access/index.php?/archives/131-Comments-on-Proposed-Anti-Counterfeiting-Treaty.html#extended)  
[3] See, for example:  
[http://www.washingtonpost.com/wp-dyn/content/article/2008/07/18/AR2008071802446.html](http://www.washingtonpost.com/wp-dyn/content/article/2008/07/18/AR2008071802446.html)  
[4] [http://www.whitehouse.gov/news/releases/2008/07/20080708-2.html](http://www.whitehouse.gov/news/releases/2008/07/20080708-2.html)

Essential Action is a public health and corporate accountability group  
located in Washington, DC. Essential Action's Access to Medicines  
Project has worked on global access to medicines issues for more than a  
decade.

For more information on our work go to www.essentialaction.org/access/  
Published by Essential Action's Access to Medicines Project  
P.O. Box 19405, Washington, DC, 20036, USA  
Tel: (1) (202) 387-8030  
www.essentialaction.org/access/

Editors: Sarah Rimmington srimmington@esssentialinformation.org  
Robert Weissman rob@essential.org

To subscribe to the free Global Access to Medicines e-Bulletin go to:  
[http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=2959](http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=2959)

--  
Sarah Rimmington  
Attorney  
Essential Action, Access to Medicines Project  
Washington, DC  
Tel: (202) 387-8030  
Cell: (202) 422-2687  
www.essentialaction.org/access/
